ML19325D126
| ML19325D126 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/1988 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Nussbaumer D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| Shared Package | |
| ML19325D099 | List: |
| References | |
| RULE-PRM-35-9 NUDOCS 8910190028 | |
| Download: ML19325D126 (2) | |
Text
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UNITED STATES 4
(
NUCLEAR REGULATORY COMMISSION
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P%SMINGTcN, D. C. 30695 JUN 2 81980 '
MEMdRANDUMFOR
_ Donald A.'Nussbaumer, Assistant Director for State Agreements Program State Local and Indian Tribe Programs, GPA L
. FROM; Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NM$$
'* $UBJECT:
APPROVAL OF NON-IND/NDA RADIQPHARMACEUT!qALS f
This is in response to your memorandum of Aprt) 19, 1988, concerning authorization to approve diagnostic imaging and therapy studies involving the use of radioactive drugs not covered by an accepted " Notice of Claimed Investigational Exemption for a New Drug" (IND) or an approved "New Drug l
Application" (NDA).
Radioactive Drug Research Comittees (RDRC) serve a function under Food and Drug Administration (FDA) regulations.
Radiation Safety Comittees serve a function under Nur, lear Regulatory Comission (NRC) regulstions.
(" Human Subjects Review Comittees" are not covered in NRC reguintory requirements).
It has been our understanding in the past that RDRC's can approve basic research studies only, and cannot approve diagnostic or therapy studies (see the FDA enclosed letter published in 1985).
Your questions pertaining to the authority of the Human Subjects Review Comittee and the Radioactive Drup Research Comittee to approve diagnostic imaging and therapy studies for non-!ND and non-NDA radioactive drugs is being referred to the FDA for l'
clarificatien of their drug regulations, j
f The NRC only authorites its licensees to use radioactive drugs in accordance with FDA requirements as a matter of administrative policy and as reflected in NRC regulations. Those drugs with an accepted IND or approved NDA are
(
t authorized for use under 10.CFR Part 35 regulations and need no further licensing action. Those non-IND and non-NDA drugs used in studies that meet all the 21 CFR Part 361.1 FDA requirements are approved by the RDRC and authorized by NRC License Item g. " Authorized Use." Specifically, the i
authorizattun to " conduct medical research" is used to express this authorization in the broad-scope medical license, anr: a specific line item is used for other medical licenses.
The functions of the Radiation Safety Comittee c/ a NRC medical use licensee
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with a Type A specific license of broad scope are outlined in 10 CFR Parts 33 and 35. The Comittee's primary responsibility is to oversee the organization's radiation safety program.
Nothing in these regulations provides the Comittee the authority to approve diagnostic imaging or therapy studies involving the use of non-IND or non-NDA radioactive 'rup.
s go3g28890605 35-09 PDR
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i Dona'd A. Nussbaumer 2-j I.
We will forward the FDA's response to you as soon as we receive it.
If you j
have any questions feel'fr,ee to contact Donni-Beth Howe, Ph.D., of my staff at 1
(301) 492-0636.
l Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NM55 i
i
Enclosure:
As stated
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